Cleared Traditional

IMX B12

K903218 · Abbott Laboratories · Chemistry
Aug 1990
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K903218 is an FDA 510(k) clearance for the IMX B12, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 23, 1990, 31 days after receiving the submission on July 23, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K903218 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1990
Decision Date August 23, 1990
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LIG — Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

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